Page contentsPage contents Key facts Decision Key facts Active substance xaluritamig Therapeutic area Neoplasms benign, malignant and unspecified (incl cysts and polyps) Decision number EMA/PE/0000221674 PIP number EMA/PE/0000221674 Pharmaceutical form(s) All pharmaceutical forms Condition(s) / indication(s) Treatment of prostate cancer Route(s) of administration All routes of administration Contact for public enquiries Amgen Europe B.V. Tel. +44 (0)1223 420305E-mail: pipenquiry@amgen.com Decision type W: decision granting a waiver in all age groups for all conditions or indications Decision date 06/12/2024 Compliance check done No Decision EMA/PE/0000221674 : EMA decision of 6 December 2024 on the granting of a product specific waiver for xaluritamigAdopted Reference Number: EMADOC-1700519818-1793219 English (EN) (200.93 KB - PDF)First published: 16/12/2025 View Share this page